Patients Discuss and Debate the Medical Outcomes from Generic Formulations

Patients Discuss and Debate the Medical Outcomes from Generic Formulations By Jeff Terkowitz When mature products face the introduction of generics, patients are often considering, or asked to consider, switching their medications. At that transition, there is a high need for Real World Data documenting patient experiences. What happens to medical outcomes when patients switch medications? Where does a business get the Real World Evidence (RWE) about patient experience that is so needed during any transition from an exclusive formulation to the availability of competitive generics? A logical place to start is with the patient consumers. After [...]

HEOR: Incorporating the Human Costs and Benefits into Drug Value

HEOR: Incorporating the Human Costs and Benefits into Drug Value By Kathleen Hoffman, PhD, MSPH In a 2007 article, “Pinning Down the Money Value of a Person’s Life,” NY Times reporter Alex Berensen wrote, “HOW much is your life worth? How about a year of life? How much is your vision worth? What about being pain-free? Able to walk unassisted? ... Economists are sometimes accused of knowing the prices of everything and the value of nothing. Now they are trying to answer what may be the most difficult question of all — the price of health.”1 Berensen [...]

A dazzle of zebras: Ehlers-Danlos Syndromes

A dazzle of zebras: Ehlers-Danlos Syndromes By Hannah Eccard On their website, The Ehlers-Danlos Society explains why people with Ehlers-Danlos Syndromes (EDS) call themselves zebras. “Medical students have been taught for decades that, ‘When you hear hoofbeats behind you, don’t expect to see a zebra.’ In other words, look for the more common and usual, not the surprising, diagnosis.” 1 People with EDS are the unexpected zebras. This rare connective tissue disorder characterized by joint hypermobility, skin elasticity and tissue fragility has recently, through the efforts of The Ehlers-Danlos Society, become more well known. Unfortunately many people [...]

What Matters Most to People Impacted by Rare Disease: An Inspire-FDA Collaboration

What Matters Most to People Impacted by Rare Disease: An Inspire-FDA Collaboration By Sara Ray What happened when we compared research strategies used to obtain patient insights? We discovered that using multiple strategies is key to gaining usable understandings. In a recent collaboration between Inspire and the FDA, we compared and contrasted patient and caregiver generated online communication with the results of one of FDA’s Voice of the Patient meetings. The Data Sets Inspire’s membership includes over 350,000 patients and caregivers living and coping with rare diseases. In the last three years, there has been 203% growth [...]

Rethinking patient engagement in clinical trials: Be part of the solution

Rethinking patient engagement in clinical trials: Be part of the solution By Kathleen D. Hoffman, PhD Seated in the waiting room of a large medical center, I overheard the bright eyed, young man behind the reception desk ask a new patient, “Would you like to learn more about participating in our research?” I smiled and thought, this is part of the solution. But it is a small part. I’ve been going to the same clinic for five years and today is the first time I’ve heard this question. I wondered if anyone would ask me - [...]